Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Primary Purpose
Shoulder Dislocation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
button plates fixation system
Non-absorbable Suture Anchor
Sponsored by
About this trial
This is an interventional other trial for Shoulder Dislocation focused on measuring button, non-absorbable suture anchor
Eligibility Criteria
Inclusion Criteria:
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect < 10%
- failure after Bankart repair.
Exclusion Criteria:
- epilepsy
- multidirectional shoulder instability
- concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
- Follow-up was less than 2 years or incomplete follow-up data.
Sites / Locations
- PekingUTH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Button Plates fixation system
Non-absorbable Suture Anchor
Arm Description
Patients receiving surgery fixed with Button Plates fixation system
Patients receiving surgery fixed with Non-absorbable suture anchor
Outcomes
Primary Outcome Measures
Rowe score
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Secondary Outcome Measures
ASES score
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
ASES score
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
ASES score
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
Full Information
NCT ID
NCT04960137
First Posted
July 4, 2021
Last Updated
July 14, 2021
Sponsor
Peking University Third Hospital
Collaborators
Hunan People's Hospital, The First Hispital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT04960137
Brief Title
Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Official Title
Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Hunan People's Hospital, The First Hispital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to conduct a comparative study through clinical trials to verify the safety and efficacy of the products in the experimental group for clinical use.
Detailed Description
The product of this clinical validation is the fixed button plate system, which is used for the reconstruction of the coracoclavicular ligament in the treatment of recurrent shoulder dislocation. The clinical trial was conducted to verify the rationality of its structural design, the convenience of its operation, and the effectiveness and safety of its clinical use. This trial was conducted in a parallel controlled trial design, the patients were divided into test and control groups to evaluate the safety and efficacy of the product.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
button, non-absorbable suture anchor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Button Plates fixation system
Arm Type
Experimental
Arm Description
Patients receiving surgery fixed with Button Plates fixation system
Arm Title
Non-absorbable Suture Anchor
Arm Type
Active Comparator
Arm Description
Patients receiving surgery fixed with Non-absorbable suture anchor
Intervention Type
Device
Intervention Name(s)
button plates fixation system
Intervention Description
The button plates fixation system consists of fixing plate, prefabricated mix, button and fuse. In the process of use, the fuse plays the role of guiding the fixed plate through, pulling the button and shortening the distance between the button and the fixed plate. The prefabricated mix is pre-worn between the button and the fixed plate, and the lead pulls the distance between the fixed plate and the button after tightening and fixing. Prefabricated mix, make mix tight and knot. Finish the preliminary work of fixing.
Intervention Type
Device
Intervention Name(s)
Non-absorbable Suture Anchor
Intervention Description
A conventional device used in surgery for shoulder dislocation.
Primary Outcome Measure Information:
Title
Rowe score
Description
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Time Frame
before surgery
Title
Rowe score
Description
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Time Frame
3 months after surgery
Title
Rowe score
Description
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
ASES score
Description
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
Time Frame
before surgery
Title
ASES score
Description
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
Time Frame
3 months after surgery
Title
ASES score
Description
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a glenoid defect ≥10%
contact sport athletes with a glenoid defect < 10%
failure after Bankart repair.
Exclusion Criteria:
epilepsy
multidirectional shoulder instability
concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
Follow-up was less than 2 years or incomplete follow-up data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoqing Cui
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PekingUTH
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
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